A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) in Non-metastatic Hormone Resistant Prostate Cancer (ENTHUSE M0)
29. august 2012 oppdatert av: AstraZeneca
A Phase III, Randomised, Placebo-controlled, Double-blind Study to Assess the Efficacy and Safety of Once-daily Orally Administered ZD4054 (Zibotentan) 10 mg in Non-metastatic Hormone-resistant Prostate Cancer Patients
Enthuse M0 is a large phase III clinical trial studying the efficacy of ZD4054 (Zibotentan) in hormone resistant prostate cancer (HRPC).
This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan) can improve progression-free survival and overall survival against a background of existing prostate cancer treatments.
ZD4054 (Zibotentan) is a new type of agent, which is thought to slow tumour growth and spread by blocking Endothelin receptor activity. This trial will look at the effects of ZD4054 (Zibotentan) in hormone resistant prostate cancer (HRPC) patients who have had rising PSA after surgical or medical castration but have no evidence of metastases.
All patients participating in this clinical trial will receive existing prostate cancer treatments in addition to trial therapy.
Half the patients will receive ZD4054 (Zibotentan) , and half the patients will receive placebo in addition to standard prostate cancer therapy. By participating in this trial there is a 50% chance that patients will receive an agent that may slow the progression of the tumour.
No patients will be deprived of standard prostate cancer therapy.
Studieoversikt
Status
Avsluttet
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
2577
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
Santa Fe, Argentina
- Research Site
-
-
Buenos Aires
-
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
- Research Site
-
-
Santa Fe
-
Rosario, Santa Fe, Argentina
- Research Site
-
-
-
-
-
Sydney, Australia
- Research Site
-
-
New South Wales
-
Darlinghurst, New South Wales, Australia
- Research Site
-
Hornsby, New South Wales, Australia
- Research Site
-
Westmead, New South Wales, Australia
- Research Site
-
Wollongong, New South Wales, Australia
- Research Site
-
-
Victoria
-
Wodonga, Victoria, Australia
- Research Site
-
-
Western Australia
-
Nedlands, Western Australia, Australia
- Research Site
-
-
-
-
-
(Wilrijk) Antwerpen, Belgia
- Research Site
-
Brussels, Belgia
- Research Site
-
Edegem, Belgia
- Research Site
-
Gent, Belgia
- Research Site
-
Kortrijk, Belgia
- Research Site
-
Leuven, Belgia
- Research Site
-
Liege, Belgia
- Research Site
-
-
-
-
-
Sao Paulo, Brasil
- Research Site
-
-
Goias
-
Goiania, Goias, Brasil
- Research Site
-
-
Minas Gerais
-
Belo Horizonte, Minas Gerais, Brasil
- Research Site
-
-
PR
-
Londrina, PR, Brasil
- Research Site
-
-
Parana
-
Curitiba, Parana, Brasil
- Research Site
-
-
RJ
-
Rio de Janeiro, RJ, Brasil
- Research Site
-
-
Rio Grande do Sul
-
Porto Alegre, Rio Grande do Sul, Brasil
- Research Site
-
-
Sao Paulo
-
Santo Andre, Sao Paulo, Brasil
- Research Site
-
-
-
-
Alberta
-
Calgary, Alberta, Canada
- Research Site
-
Edmonton, Alberta, Canada
- Research Site
-
-
British Columbia
-
Vancouver, British Columbia, Canada
- Research Site
-
Victoria, British Columbia, Canada
- Research Site
-
-
Manitoba
-
Winnipeg, Manitoba, Canada
- Research Site
-
-
Ontario
-
Burlington, Ontario, Canada
- Research Site
-
Hamilton, Ontario, Canada
- Research Site
-
Kingston, Ontario, Canada
- Research Site
-
Kitchener, Ontario, Canada
- Research Site
-
London, Ontario, Canada
- Research Site
-
North York, Ontario, Canada
- Research Site
-
Oakville, Ontario, Canada
- Research Site
-
Toronto, Ontario, Canada
- Research Site
-
-
Quebec
-
Greenfeild Park, Quebec, Canada
- Research Site
-
Montreal, Quebec, Canada
- Research Site
-
Point-Claire, Quebec, Canada
- Research Site
-
Quebec City, Quebec, Canada
- Research Site
-
Sherbrooke, Quebec, Canada
- Research Site
-
-
-
-
-
La Serena, Chile
- Research Site
-
Santiago, Chile
- Research Site
-
Temuco, Chile
- Research Site
-
Vina del Mar, Chile
- Research Site
-
-
-
-
-
Bogota, Colombia
- Research Site
-
Medellin, Colombia
- Research Site
-
-
-
-
-
Aalborg, Danmark
- Research Site
-
Frederiksberg, Danmark
- Research Site
-
Herlev, Danmark
- Research Site
-
Holstebro, Danmark
- Research Site
-
Kobenhavn, Danmark
- Research Site
-
Odense, Danmark
- Research Site
-
Roskilde, Danmark
- Research Site
-
-
-
-
-
Barnaul, Den russiske føderasjonen
- Research Site
-
Kursk, Den russiske føderasjonen
- Research Site
-
Moscow, Den russiske føderasjonen
- Research Site
-
Sochi, Den russiske føderasjonen
- Research Site
-
St.Petersburg, Den russiske føderasjonen
- Research Site
-
Voronezh, Den russiske føderasjonen
- Research Site
-
-
Omsk region
-
Omsk, Omsk region, Den russiske føderasjonen
- Research Site
-
-
Russia
-
Izhevsk, Russia, Den russiske føderasjonen
- Research Site
-
-
Tomsk Region
-
Tomsk, Tomsk Region, Den russiske føderasjonen
- Research Site
-
-
-
-
-
Helsinki, Finland
- Research Site
-
Joensuu, Finland
- Research Site
-
Oulu, Finland
- Research Site
-
Seinajoki, Finland
- Research Site
-
Tampere, Finland
- Research Site
-
-
-
-
Arizona
-
Tucson, Arizona, Forente stater
- Research Site
-
-
California
-
Greenbrae, California, Forente stater
- Research Site
-
Los Angeles, California, Forente stater
- Research Site
-
San Diego, California, Forente stater
- Research Site
-
San Francisco, California, Forente stater
- Research Site
-
-
Colorado
-
Denver, Colorado, Forente stater
- Research Site
-
-
Connecticut
-
Norwich, Connecticut, Forente stater
- Research Site
-
-
District of Columbia
-
Washington, District of Columbia, Forente stater
- Research Site
-
-
Florida
-
Boca Raton, Florida, Forente stater
- Research Site
-
Miami, Florida, Forente stater
- Research Site
-
Ocala, Florida, Forente stater
- Research Site
-
Port St. Lucie, Florida, Forente stater
- Research Site
-
-
Georgia
-
Atlanta, Georgia, Forente stater
- Research Site
-
Macon, Georgia, Forente stater
- Research Site
-
-
Kansas
-
Kansas City, Kansas, Forente stater
- Research Site
-
-
Louisiana
-
New Orleans, Louisiana, Forente stater
- Research Site
-
-
Maryland
-
Baltimore, Maryland, Forente stater
- Research Site
-
Rockville, Maryland, Forente stater
- Research Site
-
-
Minnesota
-
Minneapolis, Minnesota, Forente stater
- Research Site
-
-
Nebraska
-
Lincoln, Nebraska, Forente stater
- Research Site
-
-
Nevada
-
Las Vegas, Nevada, Forente stater
- Research Site
-
-
New York
-
Brooklyn, New York, Forente stater
- Research Site
-
-
North Carolina
-
Chapel Hill, North Carolina, Forente stater
- Research Site
-
-
North Dakota
-
Bismarck, North Dakota, Forente stater
- Research Site
-
-
Ohio
-
Canton, Ohio, Forente stater
- Research Site
-
Cincinnati, Ohio, Forente stater
- Research Site
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Forente stater
- Research Site
-
Pittsburgh, Pennsylvania, Forente stater
- Research Site
-
-
South Carolina
-
Charleston, South Carolina, Forente stater
- Research Site
-
Mystle Beach, South Carolina, Forente stater
- Research Site
-
Raleigh, South Carolina, Forente stater
- Research Site
-
-
Tennessee
-
Memphis, Tennessee, Forente stater
- Research Site
-
Nashville, Tennessee, Forente stater
- Research Site
-
-
Texas
-
San Antonio, Texas, Forente stater
- Research Site
-
-
Vermont
-
Burlington, Vermont, Forente stater
- Research Site
-
-
Washington
-
Seattle, Washington, Forente stater
- Research Site
-
Wenatchee, Washington, Forente stater
- Research Site
-
-
Wisconsin
-
Milwaukee, Wisconsin, Forente stater
- Research Site
-
-
-
-
-
Caen cedex, Frankrike
- Research Site
-
Creteil, Frankrike
- Research Site
-
Lille, Frankrike
- Research Site
-
Lyon, Frankrike
- Research Site
-
Lyon cedex 03, Frankrike
- Research Site
-
Marseille, Frankrike
- Research Site
-
Montpellier, Frankrike
- Research Site
-
Orleans Cedex, Frankrike
- Research Site
-
Paris, Frankrike
- Research Site
-
Pierre Benite cedex, Frankrike
- Research Site
-
Poitiers Cedex, Frankrike
- Research Site
-
Reims, Frankrike
- Research Site
-
Reims cedex, Frankrike
- Research Site
-
Rennes cedex 9, Frankrike
- Research Site
-
Rouen, Frankrike
- Research Site
-
Suresnes, Frankrike
- Research Site
-
Toulouse, Frankrike
- Research Site
-
Vandoeuvre-les-Nancy cedex, Frankrike
- Research Site
-
Villejuif, Frankrike
- Research Site
-
-
-
-
-
New Delhi, India
- Research Site
-
-
Gujarat
-
Ahmedabad, Gujarat, India
- Research Site
-
Nadiad, Gujarat, India
- Research Site
-
-
Kerala
-
Kochi, Kerala, India
- Research Site
-
-
Maharashtra
-
Pune, Maharashtra, India
- Research Site
-
-
Tamil Nadu, India
-
Chennai, Tamil Nadu, India, India
- Research Site
-
-
Uttar Pradesh
-
Lucknow, Uttar Pradesh, India
- Research Site
-
-
West Bengal
-
Kolkota, West Bengal, India
- Research Site
-
-
-
-
-
Dublin, Irland
- Research Site
-
Dublin 7, Irland
- Research Site
-
Dublin 8, Irland
- Research Site
-
-
-
-
-
Be'er Sheva, Israel
- Research Site
-
Be'er-Ya'akov, Israel
- Research Site
-
Haifa, Israel
- Research Site
-
Holon, Israel
- Research Site
-
Jeruslaem, Israel
- Research Site
-
Petah-Tikva, Israel
- Research Site
-
Tel-HaShomer - Ramat Gan, Israel
- Research Site
-
-
-
-
-
Ancona, Italia
- Research Site
-
Bari, Italia
- Research Site
-
Bergamo, Italia
- Research Site
-
Bologna, Italia
- Research Site
-
Catania, Italia
- Research Site
-
Como, Italia
- Research Site
-
Firenze, Italia
- Research Site
-
Genova, Italia
- Research Site
-
Messina, Italia
- Research Site
-
Milano, Italia
- Research Site
-
Pisa, Italia
- Research Site
-
Rome, Italia
- Research Site
-
Terni, Italia
- Research Site
-
Varese, Italia
- Research Site
-
-
-
-
-
Kyoto, Japan
- Research Site
-
Nagasaki, Japan
- Research Site
-
-
Aomori
-
Hirosaki-City, Aomori, Japan
- Research Site
-
-
Chiba
-
Chiba-City, Chiba, Japan
- Research Site
-
Narashino-city, Chiba, Japan
- Research Site
-
-
Ehime
-
Matsuyama-City, Ehime, Japan
- Research Site
-
-
Fukuoka
-
Fukuoka-City, Fukuoka, Japan
- Research Site
-
-
Gunma
-
Maebashi-City, Gunma, Japan
- Research Site
-
-
Hiroshima
-
Otake-City, Hiroshima, Japan
- Research Site
-
-
Hokkaido
-
Sapporo-City, Hokkaido, Japan
- Research Site
-
-
Hyogo
-
Kobe-City, Hyogo, Japan
- Research Site
-
-
Ibaraki
-
Ibaraki-machi, Ibaraki, Japan
- Research Site
-
Mito-City, Ibaraki, Japan
- Research Site
-
Tsukuba-City, Ibaraki, Japan
- Research Site
-
-
Kagawa
-
Kita-gun, Kagawa, Japan
- Research Site
-
-
Kanagawa
-
Sagamihara-City, Kanagawa, Japan
- Research Site
-
-
Kyoto
-
Kamigyo-ku, Kyoto, Japan
- Research Site
-
Kyoto-City, Kyoto, Japan
- Research Site
-
-
Miyagi
-
Sendai-City, Miyagi, Japan
- Research Site
-
-
Nagano
-
Ueda-City, Nagano, Japan
- Research Site
-
-
Nara
-
Kashihara, Nara, Japan
- Research Site
-
-
Oita
-
Oita-City, Oita, Japan
- Research Site
-
-
Okayama
-
Kurashiki, Okayama, Japan
- Research Site
-
-
Osaka
-
Osaka-City, Osaka, Japan
- Research Site
-
Osaka-Sayama-City, Osaka, Japan
- Research Site
-
Suita-City, Osaka, Japan
- Research Site
-
-
Saitama
-
Wako-City, Saitama, Japan
- Research Site
-
-
Shizuoka
-
Hamamatsu-city, Shizuoka, Japan
- Research Site
-
Sunto-gun, Shizuoka, Japan
- Research Site
-
-
Tokyo
-
Bunkyo-ku, Tokyo, Japan
- Research Site
-
Fuchu_city, Tokyo, Japan
- Research Site
-
Itabashi-Ku, Tokyo, Japan
- Research Site
-
Meguro-ku, Tokyo, Japan
- Research Site
-
Minato-Ku, Tokyo, Japan
- Research Site
-
Mitaka-City, Tokyo, Japan
- Research Site
-
Shinjuku-ku, Tokyo, Japan
- Research Site
-
-
-
-
-
Beijing, Kina
- Research Site
-
Chongqing, Kina
- Research Site
-
Guangzhou City, Kina
- Research Site
-
Hubei, Kina
- Research Site
-
Jiangsu, Kina
- Research Site
-
Shanghai, Kina
- Research Site
-
Shanxi, Kina
- Research Site
-
Tianjin, Kina
- Research Site
-
Zejiang, Kina
- Research Site
-
-
Jiangsu
-
Nanjing, Jiangsu, Kina
- Research Site
-
-
Zhejiang
-
Hangzhou, Zhejiang, Kina
- Research Site
-
-
-
-
Gyeonggi-do
-
Bundang-Gu, Seongnam-si, Gyeonggi-do, Korea, Republikken
- Research Site
-
-
Pusan
-
Seo-gu, Pusan, Korea, Republikken
- Research Site
-
-
Seoul
-
Gangnam-gu, Seoul, Korea, Republikken
- Research Site
-
Seodaemun-gu, Seoul, Korea, Republikken
- Research Site
-
Seongbuk-gu, Seoul, Korea, Republikken
- Research Site
-
Songpa-gu, Seoul, Korea, Republikken
- Research Site
-
-
-
-
-
Liepaja, Latvia
- Research Site
-
Riga, Latvia
- Research Site
-
-
-
-
Ciudad de Mexico
-
Distrito Federal, Ciudad de Mexico, Mexico
- Research Site
-
-
Distrito Federal
-
Mexico DF, Distrito Federal, Mexico
- Research Site
-
-
-
-
-
Amsterdam, Nederland
- Research Site
-
Arnhem, Nederland
- Research Site
-
Eindhoven, Nederland
- Research Site
-
Hertogenbosch, Nederland
- Research Site
-
Nijmegen, Nederland
- Research Site
-
Rotterdam, Nederland
- Research Site
-
Tilburg, Nederland
- Research Site
-
-
-
-
-
Tonsberg, Norge
- Research Site
-
Trondheim, Norge
- Research Site
-
-
-
-
-
Arequipa, Peru
- Research Site
-
Bellavista, Peru
- Research Site
-
Jesus Maria, Peru
- Research Site
-
Lima, Peru
- Research Site
-
-
-
-
-
Gdynia, Polen
- Research Site
-
Kielce, Polen
- Research Site
-
Koscierzyna, Polen
- Research Site
-
Szczecin, Polen
- Research Site
-
Warszawa, Polen
- Research Site
-
Wroclaw, Polen
- Research Site
-
-
-
-
-
Coimbra, Portugal
- Research Site
-
Porto, Portugal
- Research Site
-
-
-
-
-
Bucuresti, Romania
- Research Site
-
Cluj-Napoca, Romania
- Research Site
-
-
Timis
-
Timisoara, Timis, Romania
- Research Site
-
-
-
-
-
Belgrade, Serbia
- Research Site
-
Nis, Serbia
- Research Site
-
Novi Sad, Serbia
- Research Site
-
-
-
-
-
A Corunna, Spania
- Research Site
-
Barcelona, Spania
- Research Site
-
Madrid, Spania
- Research Site
-
Sevilla, Spania
- Research Site
-
Valencia, Spania
- Research Site
-
-
Alicante
-
Elche, Alicante, Spania
- Research Site
-
-
Bizkaia
-
Barakaldo, Bizkaia, Spania
- Research Site
-
-
Vizcaya
-
Bilbao, Vizcaya, Spania
- Research Site
-
-
-
-
-
Cambridge, Storbritannia
- Research Site
-
Coventry, Storbritannia
- Research Site
-
Glasgow, Storbritannia
- Research Site
-
Huddersfield, Storbritannia
- Research Site
-
Liverpool, Storbritannia
- Research Site
-
London, Storbritannia
- Research Site
-
Manchester, Storbritannia
- Research Site
-
Newcastle upon Tyne, Storbritannia
- Research Site
-
-
Berkshire
-
Reading, Berkshire, Storbritannia
- Research Site
-
-
East Yorkshire
-
Cottingham, East Yorkshire, Storbritannia
- Research Site
-
-
Hertfordshire
-
Stevenage, Hertfordshire, Storbritannia
- Research Site
-
-
Kent
-
Maidstone, Kent, Storbritannia
- Research Site
-
-
Surrey
-
Guildford, Surrey, Storbritannia
- Research Site
-
-
-
-
-
Aarau, Sveits
- Research Site
-
CH-4031 Basel, Sveits
- Research Site
-
Locarno, Sveits
- Research Site
-
Zuerich, Sveits
- Research Site
-
-
-
-
-
Gothenburg, Sverige
- Research Site
-
Helsingborg, Sverige
- Research Site
-
Jonkoping, Sverige
- Research Site
-
Orebro, Sverige
- Research Site
-
Stockholm, Sverige
- Research Site
-
Uppsala, Sverige
- Research Site
-
-
-
-
-
Pietermaritzburg, Sør-Afrika
- Research Site
-
Pretoria, Sør-Afrika
- Research Site
-
-
Cape Town
-
Observatory, Cape Town, Sør-Afrika
- Research Site
-
Tygerberg, Cape Town, Sør-Afrika
- Research Site
-
-
Durban
-
Overport, Durban, Sør-Afrika
- Research Site
-
-
Johannesburg
-
Parktown, Johannesburg, Sør-Afrika
- Research Site
-
-
-
-
-
Taipei, Taiwan
- Research Site
-
-
-
-
-
Brno, Tsjekkisk Republikk
- Research Site
-
Hradec Kralove, Tsjekkisk Republikk
- Research Site
-
Jablonec nad Nisou, Tsjekkisk Republikk
- Research Site
-
Kromeriz, Tsjekkisk Republikk
- Research Site
-
Olomouc, Tsjekkisk Republikk
- Research Site
-
Prague 2, Tsjekkisk Republikk
- Research Site
-
Prague 4, Tsjekkisk Republikk
- Research Site
-
Prague 6, Tsjekkisk Republikk
- Research Site
-
Praha, Tsjekkisk Republikk
- Research Site
-
Usti nad Labem, Tsjekkisk Republikk
- Research Site
-
-
-
-
-
Ankara, Tyrkia
- Research Site
-
Istanbul, Tyrkia
- Research Site
-
Izmir, Tyrkia
- Research Site
-
-
-
-
-
Augsburg, Tyskland
- Research Site
-
Bad Ems, Tyskland
- Research Site
-
Berlin, Tyskland
- Research Site
-
Bonn, Tyskland
- Research Site
-
Borken, Tyskland
- Research Site
-
Chemnitz, Tyskland
- Research Site
-
Emmendingen, Tyskland
- Research Site
-
Fuerth, Tyskland
- Research Site
-
Gelsenkirchen-Buer, Tyskland
- Research Site
-
Germering, Tyskland
- Research Site
-
Goettingen, Tyskland
- Research Site
-
Holzminden, Tyskland
- Research Site
-
Kirchheim/Teck, Tyskland
- Research Site
-
Leipzig, Tyskland
- Research Site
-
Lubeck, Tyskland
- Research Site
-
Mannheim, Tyskland
- Research Site
-
Muehlacker, Tyskland
- Research Site
-
Muehlheim an der Ruhr, Tyskland
- Research Site
-
Muenchen, Tyskland
- Research Site
-
Muenchen-Planegg, Tyskland
- Research Site
-
Muenster, Tyskland
- Research Site
-
Reutlingen, Tyskland
- Research Site
-
Rostock, Tyskland
- Research Site
-
Tuebingen, Tyskland
- Research Site
-
Waltshut-Tiengen, Tyskland
- Research Site
-
Wuppertal, Tyskland
- Research Site
-
-
-
-
-
Budapest, Ungarn
- Research Site
-
Debrecen, Ungarn
- Research Site
-
Gyor, Ungarn
- Research Site
-
Miskolc, Ungarn
- Research Site
-
Nyiregyhaza, Ungarn
- Research Site
-
Szeged, Ungarn
- Research Site
-
Szekesfehervar, Ungarn
- Research Site
-
-
-
-
-
Graz, Østerrike
- Research Site
-
Innsbruck, Østerrike
- Research Site
-
Wels, Østerrike
- Research Site
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Mann
Beskrivelse
Inclusion Criteria:
Patients who answer TRUE to the following criteria may be eligible to participate in this study.
- Confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate) that has NOT spread to the other parts of the body (metastases). Patients with lymph node involvement may be eligible if specified criteria is met.
- Increasing Prostate Specific Antigen (PSA), collected within one year of enrollment
- Currently receiving treatment with surgical or medical castration
Exclusion Criteria:
Patients who answer TRUE to the following may NOT be eligible to participate in this study.
- Currently using opiate based pain killers for cancer related pain
- Previous treatment with chemotherapy (paclitaxel, docetaxel, and mitoxantrone). Prior targeted cancer therapies are permitted if received during a previous clinical trial
- Suffering from heart failure or had a myocardial infarction within last 6 months
- A history of epilepsy or seizures
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Placebo komparator: Placebo
Matchende placebo
|
Matching Plcebo oral tablet once daily
|
|
Eksperimentell: ZD4054
ZD4054 (Zibotentan)
|
10 mg once daily oral dose
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall Survival
Tidsramme: From date of randomization until date of death, assessed up to 33 months
|
Number of participants who have died at early analysis data cut off (DCO)
|
From date of randomization until date of death, assessed up to 33 months
|
|
Progression Free Survival
Tidsramme: Participants were followed up for progression every 4 weeks for the first 16 weeks then every 16 weeks
|
Number of participants who have a progression event at the early analysis DCO, where progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline
|
Participants were followed up for progression every 4 weeks for the first 16 weeks then every 16 weeks
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Health Related Quality of Life
Tidsramme: Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks
|
Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks
|
|
Time to Prostate-specific Antigen (PSA) Progression
Tidsramme: Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks
|
Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks
|
|
Time to Symptomatic Progression
Tidsramme: Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks
|
Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Kurt Miller, Prof., M.D., Charite University, Berlin, Germany
- Hovedetterforsker: Tia Higano, MD, University of Washington
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. januar 2008
Primær fullføring (Faktiske)
1. januar 2011
Studiet fullført (Faktiske)
1. mai 2011
Datoer for studieregistrering
Først innsendt
24. januar 2008
Først innsendt som oppfylte QC-kriteriene
21. februar 2008
Først lagt ut (Anslag)
29. februar 2008
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
3. september 2012
Siste oppdatering sendt inn som oppfylte QC-kriteriene
29. august 2012
Sist bekreftet
1. april 2012
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- D4320C00015
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Palcebo
-
Ain Shams UniversityRekruttering
-
Maastricht University Medical CenterTop Institute Food and NutritionFullførtOvervekt | Type 2 diabetesNederland
-
Chinese PLA General HospitalUkjentDysfunksjon i venstre ventrikkel | Kronisk myokardiskemi | Gammelt hjerteinfarktKina
-
Institute of Liver and Biliary Sciences, IndiaFullført
-
University Hospital, GrenobleAGIR à DomFullført
-
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate...Fullført
-
Fudan UniversityRekrutteringST Elevation Hjerteinfarkt | Perkutan koronar intervensjonKina
-
BioprojetFullførtBehandling av overdreven søvnighet på dagtid ved narkolepsiFrankrike
-
Jiangsu HengRui Medicine Co., Ltd.Påmelding etter invitasjon